ACL Reconstruction Techniques for Anterior Cruciate Ligament Injury

Overseen By Whitney Hovater, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neuromuscular, Neurological, Fractures, Dislocations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which surgical technique better repairs a torn ACL (a key ligament in the knee) in young people. It compares two ACL reconstruction methods: one using a tendon-bone graft and the other using an all-soft-tissue graft. The goal is to identify which method results in better recovery and outcomes in the short, intermediate, and long term. Teens aged 12 to 19 planning their first ACL reconstruction may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these ACL reconstruction techniques are safe?

Research shows that both types of grafts used for ACL (anterior cruciate ligament) reconstruction are generally well-tolerated, but each has specific safety considerations.

For the Tendon-Bone Graft, studies have found a failure rate of about 5.2%, with the graft not working as intended in approximately 5 out of 100 cases. Another study reported that about 11.7% of these grafts tear. Despite these risks, many patients still experience successful outcomes.

For the All-Soft-Tissue Graft, results are generally positive but mixed. Some reports show excellent outcomes, though risks include knee weakness and potential long-term issues if the drilled hole in the bone enlarges, which could affect the graft's stability.

In summary, both graft types have risks, but research has shown they can be effective for many patients. Always consult your healthcare provider to understand what these findings mean for you personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these ACL reconstruction techniques because they explore innovative ways to improve knee stability and recovery. The Tendon-Bone Graft technique uses the Quadriceps Tendon, aiming to offer a stronger and more secure fixation compared to traditional grafts like the hamstring or patellar tendon. Meanwhile, the All-Soft-Tissue Graft is designed to be less invasive, potentially reducing recovery time and postoperative discomfort. These approaches could lead to better outcomes for patients by enhancing graft integration and minimizing complications.

What evidence suggests that this trial's ACL reconstruction techniques could be effective?

This trial will compare two common methods for ACL reconstruction: the tendon-bone graft and the all-soft-tissue graft. Participants in one arm will receive the tendon-bone graft, often using the patellar tendon, which provides strong knee stability and excellent results, though it might cause more knee pain. Participants in the other arm will receive the all-soft-tissue graft, which uses the quadriceps tendon without bone and tends to have a lower chance of failing, working well especially for active individuals. Both methods have shown good to excellent results, but the best choice depends on individual needs and possible side effects like knee pain or graft failure. ^{1 6 7 8 9}

Who Is on the Research Team?

Stephanie Mayer, MD

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 12-19 who need their first ACL reconstruction due to injury or tear. It's not for those with neuromuscular issues, neurological injuries, recent severe leg trauma, or systemic/musculoskeletal conditions.

Inclusion Criteria

I am either male or female.

I am between 12 and 19 years old.

I am having my first ACL surgery.

Exclusion Criteria

I have a diagnosis related to my body's systems or bones and muscles.

I had surgery for a leg injury within 2 years before my ACL injury.

You have a pre-existing neurological condition or injury affecting your muscles or nerves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative

Participants undergo ACL reconstruction using either the tendon-bone or all-soft-tissue graft technique and are monitored for immediate perioperative outcomes.

1-2 weeks

Rehabilitation and Intermediate Follow-up

Participants engage in physical therapy to achieve milestones related to return to sports clearance, with evaluations at 3, 6, and 12 months post-operative.

6 months to 1 year

Regular physical therapy visits

Long-term Follow-up

Participants are monitored for long-term outcomes including graft failure rate and patient-reported outcomes at 24 months and 5 years post-operative.

5 years

Follow-up visits at 24 months and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• ACL Reconstruction

Trial Overview The study compares two surgical techniques for pediatric ACL reconstruction: one using a tendon-bone graft and the other an all-tendon graft. The goal is to see which method leads to better outcomes in the short, medium, and long term.

How Is the Trial Designed?

Group I: Tendon-Bone Graft Active Control 1 Intervention

Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.

Group II: All-Soft-Tissue Graft Active Control 1 Intervention

Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

ACL reconstruction is a generally safe and effective procedure for knee stability, but infections, although rare, can lead to serious complications and poor outcomes.

Early diagnosis and treatment of infections with culture-specific antibiotics and debridement are crucial to prevent further damage to the knee, while the type of graft used does not appear to influence infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infections in anterior cruciate ligament reconstruction. Stucken, C., Garras, DN., Shaner, JL., et al.[2022]

In a study of 224 patients, combining anterolateral ligament reconstruction (ALLR) with anterior cruciate ligament reconstruction (ACLR) showed a significantly lower rate of reoperations for cyclops syndrome compared to isolated ACLR (0% vs 8.9%).

The combined ACL + ALLR procedure did not increase the risk of adverse events and resulted in better subjective knee function scores, indicating it may be a safer and more effective option for ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Sonnery-Cottet, B., Pioger, C., Vieira, TD., et al.[2022]

The anterior cruciate ligament (ACL) is crucial for knee function, and its damage can lead to serious issues like joint degeneration, highlighting the importance of effective reconstruction techniques.

Current ACL reconstruction methods using autografts and allografts aim to replicate the biomechanical properties of the native ligament, with double-bundle techniques showing superior stability compared to single-bundle methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament (ACL) injuries: A review on the newest reconstruction techniques. Gerami, MH., Haghi, F., Pelarak, F., et al.[2022]

In a study of 100 patients undergoing ACL reconstruction, the All-Inside technique showed significantly better improvement in knee function and stability compared to the Anatomic Accessory Medial Portal technique, as measured by various clinical scores and tests.

The All-Inside technique resulted in superior scores on the IKDC Subjective Knee Score, Lysholm Knee Score, Knee Society Score, and Visual Analog Score, indicating it may be a more effective surgical option for ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of the Results of the Anatomic Medial Portal and All-inside Arthroscopic ACL Reconstruction. Shantanu, K., Kushwaha, SS., Kumar, D., et al.[2020]

Most studies suggest that applying a graft tension of around 90 N during ACL reconstruction leads to the best outcomes, indicating the importance of proper tension for successful surgery.

Fixing the graft at a knee-flexion angle of 30° appears to provide superior biomechanical advantages, although there is no clear consensus on the best type of fixation implant for clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tibial-graft fixation methods on anterior cruciate ligament reconstructions: a literature review. Pereira, VL., Medeiros, JV., Nunes, GRS., et al.[2021]

In a study analyzing 104,255 ACL reconstructions over 20 years, serious complications occurred in only 0.65% of cases within 90 days, indicating a low overall risk of adverse events after surgery.

Approximately 3% of patients required further ACL reconstruction or meniscal surgery within 5 years, highlighting the importance of understanding potential long-term outcomes when making treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of Adverse Outcomes and Revision Surgery After Anterior Cruciate Ligament Reconstruction: A Study of 104,255 Procedures Using the National Hospital Episode Statistics Database for England, UK. Abram, SGF., Judge, A., Beard, DJ., et al.[2020]

A young patient developed a rare complication, a pseudoaneurysm of the supero-lateral genicular artery, following an anterior cruciate ligament reconstruction combined with a meniscal suture, highlighting the potential risks associated with arthroscopic procedures.

The pseudoaneurysm was successfully treated using ultrasonography-guided embolization with thrombin, demonstrating an effective intervention for this uncommon complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudaneurysm of the superolateral genicular artery following an anterior cruciate ligament reconstruction. Glanz, L.[2021]

Recent biomechanical studies indicate that more horizontal femoral tunnel placement in ACL reconstruction enhances rotational stability, which is crucial for knee function.

Clinical studies show that anatomic ACL reconstructions, which better mimic the natural ACL footprint, lead to improved patient outcomes compared to traditional techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning to anatomic anterior cruciate ligament graft placement. Sohn, DH., Garrett, WE.[2019]

In a study of 21,686 ACL reconstructions from 2007 to 2014, surgeons significantly shifted their femoral tunnel drilling techniques, moving away from tibial tunnel drilling and increasing the use of medial and lateral portal drilling methods.

The use of first-generation bioabsorbable fixation decreased, while biocomposite fixation became more popular, yet the overall revision rates for ACL surgeries remained stable throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Technique Trends in Primary ACL Reconstruction from 2007 to 2014. Tibor, L., Chan, PH., Funahashi, TT., et al.[2022]

Recent advancements in knee ACL reconstruction focus on restoring the native anatomy and biomechanics of the ligament, aiming for a stable and pain-free knee joint that allows patients to return to their previous activity levels.

Innovations include a shift towards anatomic reconstruction techniques, a variety of graft options, and reinforcement methods like anterolateral ligament reconstruction, which collectively aim to reduce the risk of rerupture and prevent osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Major Technical Advances in Knee Anterior Cruciate Ligament Reconstruction Address Anatomy, Biomechanics, and Healing. Paschos, NK.[2022]

ACL reconstruction is a common procedure for restoring knee stability, but improper graft placement can lead to failure, highlighting the need for precise surgical techniques.

This network meta-analysis aims to evaluate the clinical outcomes of various surgical techniques for ACL reconstruction, using a comprehensive set of outcome measures to inform patients and surgeons about the best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative risk-benefit profiles of different femoral drilling techniques in anterior cruciate ligament reconstruction: A protocol for a systematic review and network meta-analysis. Wang, N., Zhu, Z., Wu, Z., et al.[2022]

In a study of 958 patients undergoing ACL reconstruction, the overall complication rate was 39%, with anterior knee pain, stiffness, and secondary meniscal lesions being the most common issues reported.

The patellar tendon graft showed a significantly lower rerupture rate compared to the hamstring graft (3.1% vs 7%), while complications related to hardware were more frequent in the hamstring group, suggesting that graft choice can impact postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications After Anterior Cruciate Ligament Reconstruction and Their Relation to the Type of Graft: A Prospective Study of 958 Cases. Rousseau, R., Labruyere, C., Kajetanek, C., et al.[2020]

The transtibial technique for ACL reconstruction, while traditionally criticized for its limitations in creating anatomic femoral tunnels, can be modified to achieve better tunnel positioning and graft orientation.

This Technical Note outlines a refined approach to anatomic transtibial ACL reconstruction, potentially improving outcomes for patients undergoing this common orthopedic procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transtibial Anterior Cruciate Ligament Reconstruction: Tips for a Successful Anatomic Reconstruction. Manderle, BJ., Beletsky, A., Gorodischer, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3438864/

Clinical Outcomes After Anterior Cruciate Ligament ... Clinical outcomes of autograft and allograft anterior cruciate ligament (ACL) reconstructions are mixed, with some reports of excellent to good outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324002342

Primary All-Soft Tissue Quadriceps Tendon Autograft ... Conclusions. ASTQ ACLR with STA in a young athletic patient population may result in a low graft failure rate while maintaining satisfactory patient outcomes at ...

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(21)00497-7/fulltext

Revision Anterior Cruciate Ligament Using Soft Tissue ... The authors demonstrated at 42.2 months, mean IKDC scores significantly improved (54.3 ± 13.0 vs 82.8 ±13.8) with 83.3% of the patients (28.5 points) surpassing ...

4. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00323-2/fulltext

All-Inside Anterior Cruciate Ligament Reconstruction Using ... We present a technique demonstrating an all-inside ACL reconstruction using a full-thickness all-soft-tissue quadriceps tendon autograft (ASTQA) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X20300845

Systematic Review Allograft for Anterior Cruciate Ligament ... Similarly, the other study reported on a graft failure rate of 13 of 43 patients (30.2%) in the allograft group as compared with 3 of 40 patients (7.5%) in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11873487/

All-Inside Anterior Cruciate Ligament Reconstruction Using ... This technique describes a primary anterior cruciate ligament (ACL) reconstruction with a full-thickness all-soft-tissue quadriceps tendon autograft with ...

7. sportsmed.org sportsmed.org/membership/sports-medicine-update/spring-2024/evolving-concepts-in-acl-surgery

Evolving Concepts in Anterior Cruciate Ligament Surgery The purpose of this review is to discuss the newest data on ACL reconstruction (ACLR) graft selection, lateral augmentation techniques, and ACL repair.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118315243

Comparison of clinical outcomes after anterior cruciate ... Soft-tissue allografts are inferior to hamstring tendon autografts with respect to subjective patient evaluation and knee stability but superior in the ...

9. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00783-7/fulltext

Anterior Cruciate Ligament Reconstruction Graft Options Patients are at risk for knee flexion weakness, saphenous nerve injury, and potential graft loosening over time secondary to bone tunnel widening. Quadriceps ...